EndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG.

GUDID 00844505012270

EndoEar™ ENDOSCOPE 3.0 MM x 150 MM 70°

Grace Medical, Inc.

Otoscope, endoscopic
Primary Device ID00844505012270
NIH Device Record Key0835fd8a-663a-444e-a2bc-4b2c3b300a19
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG.
Version Model NumberEE-0370
Company DUNS030849173
Company NameGrace Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com
Phone+1(866)472-2363
Emailinfo@gracemedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100844505012270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00844505012270]

Ethylene Oxide;Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-13
Device Publish Date2019-12-05

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00844505014724 - SKULL BASE2025-10-06 EXTENDED THOMASSIN DISSECTOR DOUBLE-ENDED STAINLESS STEEL
00844505014502 - TITANIUM PISTON2025-09-26 TITANIUM PISTON 0.6MM DIA X 5.75MM L TITANIUM/RIBBON
00844505014687 - GRACE MEDICAL FLUOROPLASTIC PISTON2025-09-26 FLUOROPLASTIC PISTON 0.6MM DIA X 5.50MM L
00844505014489 - ECLIPSE PISTON2025-08-13 ECLIPSE PISTON 0.5MM DIA X 3.50MM L NITINOL/FLUOROPLASTIC
00844505014519 - TITANIUM PISTON2025-08-13 TITANIUM PISTON 0.4MM DIA X 5.75MM L TITANIUM/RIBBON
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